NCT04929028 - Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 9, 2022

Primary Completion Date

September 15, 2029

Study Completion Date

September 15, 2029

Conditions

AIDS-Related Anal CarcinomaAnal Margin Squamous Cell CarcinomaAnal Non-Keratinizing Squamous Cell CarcinomaAnal Squamous Cell CarcinomaHIV InfectionRectal Squamous Cell CarcinomaStage II Rectal Cancer AJCC v8Stage IIB Anal Cancer AJCC v8Stage III Anal Cancer AJCC v8Stage III Rectal Cancer AJCC v8

Interventions

PROCEDURE

Anoscopy

Undergo anoscopy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Capecitabine

Given PO

PROCEDURE

Colonoscopy

Undergo colonoscopy

PROCEDURE

Computed Tomography

Undergo CT or FDG PET/CT

PROCEDURE

Digital Rectal Examination

Undergo digital rectal exam

PROCEDURE

Echocardiography Test

Undergo ECHO

OTHER

Fludeoxyglucose F-18

Receive FDG

DRUG

Fluorouracil

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Lymph Node Biopsy

Undergo lymph node biopsy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI or PET/MRI

DRUG

Mitomycin

Given IV

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo FDG PET/CT or PET/MRI

PROCEDURE

Proctoscopy

Undergo proctoscopy

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Sigmoidoscopy

Undergo sigmoidoscopy

Trial Locations (13)

10019

RECRUITING

Mount Sinai West, New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

RECRUITING

Mount Sinai Hospital, New York

10461

RECRUITING

Montefiore Medical Center-Einstein Campus, The Bronx

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

19107

RECRUITING

Pennsylvania Hospital, Philadelphia

20037

RECRUITING

George Washington University Medical Center, Washington D.C.

33612

RECRUITING

Moffitt Cancer Center, Tampa

60612

RECRUITING

University of Illinois, Chicago

63110

RECRUITING

Washington University School of Medicine, St Louis

77030

RECRUITING

M D Anderson Cancer Center, Houston

94110

RECRUITING

Zuckerberg San Francisco General Hospital, San Francisco

77026-1967

RECRUITING

Lyndon Baines Johnson General Hospital, Houston

All Listed Sponsors

lead

National Cancer Institute (NCI)

NIH